Symbicort Maintenance and Reliever Therapy - Experience in Real Life Setting in Malaysia - Study Results

Symbicort Maintenance and Reliever Therapy - Experience in Real Life Setting in Malaysia (SMARTER)

This study has been completed.

Study NCT00576316 Information provided by AstraZeneca

First Received on December 17, 2007. Last Updated on November 30, 2010 History of Changes

Results First Received: November 19, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Asthma
Intervention:	Drug: Symbicort Turbuhaler 160/4.5

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
201 patients were recruited from 10 government hospital based outpatient clinics from Dec 2007 until May 2008

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Symbicort 160/4.5 Turbuhaler	Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever

Participant Flow: Overall Study

	Symbicort 160/4.5 Turbuhaler
STARTED	201 ^[1]
COMPLETED	181 ^[2]
NOT COMPLETED	20
Adverse Event	9
Withdrawal by Subject	2
Protocol Violation	9

[1]	Number of patients recruited
[2]	Number of patients who completed study

Baseline Characteristics

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Reporting Groups

	Description
Symbicort 160/4.5 Turbuhaler	Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever

Baseline Measures

	Symbicort 160/4.5 Turbuhaler
Number of Participants [units: participants]	201
Age [units: years] Mean ± Standard Deviation
Mean Age	46.73 ± 12.31
Gender [units: Participants]
Female	155
Male	46

Outcome Measures

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1. Primary:

Change in Satisfaction With Asthma Treatment Questionnaire (SATQ) Scores From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART [ Time Frame: 6 months after each patient was initially treated with Symbicort SMART ]

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2. Secondary:

Changes in Asthma Control Questionnaire (ACQ-5) Score From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART [ Time Frame: 6 months after each patient was initially treated with Symbicort SMART ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com

No publications provided

ClinicalTrials.gov Identifier:	NCT00576316 History of Changes
Other Study ID Numbers:	D5890L00027
Study First Received:	December 17, 2007
Results First Received:	November 19, 2009
Last Updated:	November 30, 2010
Health Authority:	Malaysia: Ministry of Health